NCT05911516

Brief Summary

The purpose of this study was to investigate the effects of Pennisetum purpureum health food supplementation on muscle mass and muscle strength.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 22, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

December 19, 2023

Status Verified

May 1, 2023

Enrollment Period

9 months

First QC Date

May 26, 2023

Last Update Submit

December 18, 2023

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (47)

  • Body height

    Baseline (before supplementation)

  • Body height

    8 weeks of supplementation

  • Body height

    12 weeks of supplementation

  • Body weight

    Baseline (before supplementation)

  • Body weight

    8 weeks of supplementation

  • Body weight

    12 weeks of supplementation

  • BMI (body mass index)

    Baseline (before supplementation)

  • BMI (body mass index)

    8 weeks of supplementation

  • BMI (body mass index)

    12 weeks of supplementation

  • Systolic blood pressure

    Baseline (before supplementation)

  • Systolic blood pressure

    8 weeks of supplementation

  • Systolic blood pressure

    12 weeks of supplementation

  • Diastolic blood pressure

    Baseline (before supplementation)

  • Diastolic blood pressure

    8 weeks of supplementation

  • Diastolic blood pressure

    12 weeks of supplementation

  • ASM (Appendicular Skeletal Muscle Mass)

    12 weeks of supplementation

  • ASM (Appendicular Skeletal Muscle Mass)

    8 weeks of supplementation

  • Upper Arm Circumference

    Baseline (before supplementation)

  • Upper Arm Circumference

    8 weeks of supplementation

  • Upper Arm Circumference

    12 weeks of supplementation

  • Thigh Circumference

    Baseline (before supplementation)

  • Thigh Circumference

    8 weeks of supplementation

  • Thigh Circumference

    12 weeks of supplementation

  • Grip Strength

    Baseline (before supplementation)

  • Grip Strength

    8 weeks of supplementation

  • Grip Strength

    12 weeks of supplementation

  • 10-Meter Walk Test

    Baseline (before supplementation)

  • 10-Meter Walk Test

    8 weeks of supplementation

  • 10-Meter Walk Test

    12 weeks of supplementation

  • Testosterone level

    Baseline (before supplementation)

  • Testosterone level

    8 weeks of supplementation

  • Testosterone level

    12 weeks of supplementation

  • Cortisol level

    Baseline (before supplementation)

  • Cortisol level

    8 weeks of supplementation

  • Cortisol level

    12 weeks of supplementation

  • Growth Hormone level

    Baseline (before supplementation)

  • Growth Hormone level

    8 weeks of supplementation

  • Growth Hormone level

    12 weeks of supplementation

  • Insulin-like Growth Factor-1

    Baseline (before supplementation)

  • Insulin-like Growth Factor-1

    8 weeks of supplementation

  • Insulin-like Growth Factor-1

    12 weeks of supplementation

  • follistain level

    Baseline (before supplementation)

  • follistain level

    8 weeks of supplementation

  • follistain level

    12 weeks of supplementation

  • myostain level

    Baseline (before supplementation)

  • myostain level

    8 weeks of supplementation

  • myostain level

    12 weeks of supplementation

Study Arms (2)

Pennisetum purpureum group

EXPERIMENTAL
Dietary Supplement: Pennisetum purpureum

Placebo group

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

Pennisetum purpureumDIETARY_SUPPLEMENT

300mg Participants received 900mg of Pennisetum purpureum orally daily for 12 weeks

Pennisetum purpureum group
PlaceboDIETARY_SUPPLEMENT

Placebo

Placebo group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult between 18-75 years old
  • skeletal muscle mass in extremities by dual-energy X-ray absorptiometry less than 7.0 kg/m2 in men and less than 5.4 kg/m2 in women
  • one of the following criteria were met: (1) handgrip strength less than 28 kg in men and less than 18 kg in women and (2) 5-time chair stand test over than 12 seconds

You may not qualify if:

  • The volunteers have history of cardiovascular, liver, kidney, and diabetes mellitus
  • acute sport injury
  • participated in any clinical trials or experimental research in the last 3 months before our experiment
  • taking supplement during the experimental period
  • did not maintain their regular eating habit or drink alcohol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University

Taipei, 110, Taiwan

RECRUITING

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Central Study Contacts

Ming Ta Yang, Doctorate

CONTACT

886-2-27361661yangrugby@tmu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
A double-blind, matched-pair study design
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were assigned to either the experimental (n=20) or placebo (n=20) group according to their body composition, upper arm circumference, and lower thigh circumference.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2023

First Posted

June 22, 2023

Study Start

June 1, 2023

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

December 19, 2023

Record last verified: 2023-05

Locations

TW(1)